FDA Recall Open, Classified

True 3D Viewer, Model: EP-00003

Recall: Z-1785-2025 · Initiated February 21, 2018

Recall

Recall Number: Z-1785-2025
Event Number: 96674
Firm: Echopixel, Inc.
FEI Number: 3011501361
Product Code: LLZ
Status: Open, Classified
Root Cause: Device Design
Initiated: February 21, 2018
Posted: May 16, 2025
Address: 780 Montague Expy, Ste 305, San Jose, CA, 95131-1317

Description

Reason

With certain software versions, import of enhanced ultrasound formatted data/ultrasound images into 3D viewer, (for digital image processing/review/analysis/communication/media interchange acquired from CT/MRI/ultrasound, and pre-operative analysis of surgical options), can result in incorrect display of image orientation, which could result in misdiagnosis or incorrect surgical treatment plan.

Action

On 2/21/2018, correction notices were emailed to customers who were asked to do the following: a) Affected software versions should not be used with Enhanced 3D Ultrasound DICOM compliant volumes or Philips 3DDCM. b) If clinicians are utilizing Enhanced 3D Ultrasound DICOM compliant volumes or Philips 3DDCM volume data sets, verify, retrospectively, any potential risk to health to patients and further determine if patients need to be reevaluated and report this information to the firm. c) Pass a copy of this notice to those staff members who need to be aware of the issue and maintain awareness for a three-month period. d)If devices were transferred to other departments or organizations, provide a copy of this notice to these consignees. Firm will contact customers to provide information about the timing and delivery mechanisms of the software upgrade. If you have questions, contact the firm at: 1-844-273-7766 x2

Distribution

Worldwide - US Nationwide distribution in the states of CA, OH, NJ, PA, MA, FL, CT, TX, LA, MI, MN and the country of CA.

Quantity